Cannabis Firm To Debut On Nasdaq Today, CTIC Plunges, IMMU To Face FDA In Jan
Today’s Daily Dose brings you news about the IPO of a cannabis firm; stock offerings of Evolus and Cara, upcoming regulatory catalyst of Immunomedics and an update on CTI Biopharma’s Type B meeting with the FDA for its lead product candidate Pacritinib.
Cara Therapeutics Inc. (CARA) has offered to sell 4.5 million shares of its common stock at a public offering price of $19.00 each.
The gross proceeds from the offering are expected to be approximately $85.5 million. The offering is expected to close on or about July 23, 2018.
The underwriters have been granted a 30-day option to purchase up to 675,000 additional shares.
Last month, the Company reported positive results from its adaptive Phase 2/3 trial of I.V. CR845 in patients undergoing abdominal surgeries. A phase 2 trial of Oral KORSUVA for the treatment of pruritus in stage III-V (moderate-to-severe) chronic kidney disease patients was initiated as recently as last week.
CARA closed Wednesday’s trading at $19.82, down 8.24%.
Shares of CTI BioPharma Corp. (CTIC) slumped more than 43% on Wednesday after the company provided an update on the Type B meeting with the FDA for its lead product candidate Pacritinib.
Based on the FDA feedback, the Company plans to conduct a randomized Phase 3 study of Pacritinib in patients with myelofibrosis. Investors were hoping that the Company will be able to file for approval of Pacritinib if the ongoing phase II study, dubbed PAC203, yields positive results.
PAC203 is expected to complete enrollment by the end of 2018, with full top-line data expected in the second quarter of 2019.
The new phase III study of Pacritinib in patients with myelofibrosis is expected to open in 2019.
CTIC closed Wednesday’s trading at $2.26, down 43.36%. In after-hours, the stock was up 3.54% at $2.34.
Evolus Inc. (EOLS) has offered to sell 4 million shares of its common stock at a public offering price of $20.00 each.
The offering consists of 3 million shares offered by Evolus and 1 million shares offered by a selling stockholder of Evolus, resulting in aggregate net proceeds of approximately $56.4 million to Evolus and approximately $18.8 million to the selling stockholder.
Evolus will not receive any proceeds from the sale of shares by the selling stockholder.
The offering is expected to close on or about July 23, 2018, subject to satisfaction of customary closing conditions.
The underwriters have a 30-day option period to purchase up to an additional 600,000 shares.
The Company is developing DWP-450 for the treatment of glabellar lines, also known as frown lines, in adult patients, a rival to Allergan’s (AGN) Botox.
In May of this year, the FDA rejected the Company’s Biologics License Application for DWP-450. There were deficiencies in items related to Chemistry, Manufacturing, and Controls (“CMC”) processes that led to the rejection. However, no deficiencies were related to clinical or non-clinical matters.
The Company expects to resubmit DWP-450 NDA to the FDA next month (August).
EOLS closed Wednesday’s trading at $21.32, down 4.52%. In after-hours, the stock fell another 2.81% to $20.72.
Immunomedics Inc.’s (IMMU) Biologics License Application for Sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer has been accepted for priority review by the FDA, with a decision expected on January 18, 2019.
If approved, Sacituzumab govitecan would be the first and only antibody-drug conjugate approved for the treatment of metastatic triple-negative breast cancer.
The filing is based on phase I/II data of Sacituzumab govitecan in metastatic triple-negative breast cancer.
IMMU closed Wednesday’s trading at $25.69, up 1.14%. The stock touched a new 52-week high of $27.33 in intra-day trading.
Shares of Tilray Inc. (TLRY) are expected to begin trading on the Nasdaq Global Select Market on July 19, 2018.
Tilray is involved in medical cannabis research, cultivation, processing and distribution, and is focused on becoming a leader in the adult-use cannabis market in Canada once it is legalized.
The Company is offering 6.52 million shares of Class 2 common stock in the United States and certain other countries except Canada at a price to the public of US$17.00 each. About 2.47 million shares of Class 2 common stock will be offered in Canada and certain other countries except the United States at a price to the public of C$22.45.
In addition, Tilray has granted the U.S. underwriters a 30-day over-allotment option to purchase up to 978,600 additional shares of Class 2 common stock and the Canadian underwriters a 30-day over-allotment option to purchase up to 371,400 additional Subordinate Voting Shares.
The offering is expected to close on July 23, 2018.
This Week’s Biotech IPOs
by RTTNews Staff Writer
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